U2 Total Knee System: Incorrect Implant Orientation Risk
United Orthopedic Corp. recalls U2 Total Knee System femoral offset bushings (model 9323-5310) due to potential incorrect implant orientation from engraved numbering errors.
Lower-risk recall
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
What happened, in plain English
United Orthopedic Corp. is recalling U2 Total Knee System femoral offset bushings (0mm and 4mm models) because the engraved numbering may be incorrect, leading to improper implant alignment during surgery. This could cause improper joint function or complications after surgery. Read more at govinfonow.com/recall/315097-u2-total-knee-system-incorrect-implant-orientation-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/315097-u2-total-knee-system-incorrect-implant-orientation-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2897-2026
Cite this page
“U2 Total Knee System: Incorrect Implant Orientation Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/315097-u2-total-knee-system-incorrect-implant-orientation-risk. Based on FDA recall #Z-2897-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2897-2026%22&limit=1).
Why it’s dangerous
The engraved numbering on the bushing may be incorrect, which could lead to the implant being oriented improperly during surgery. This might cause improper joint alignment and potential complications after the procedure.
Who’s affected
Surgical teams using the U2 Total Knee System femoral offset bushings (model 9323-5310) are affected. Surgeons and medical staff performing knee replacements are most at risk if the bushing is used incorrectly.
How to tell if you have this one
Check for the model number 9323-5310 on the U2 Total Knee System femoral offset bushing (0mm or 4mm). The product was sold with lot code 25FC58 and UDI-DI 04719886908060.
- Brand
U2- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution in the states of Texas and Michigan.
| Recall number | Product, codes & lots |
|---|---|
| Z-2897-2026 | Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A; Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58 |
| Z-2898-2026 | Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A; Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64 |
What to do — step by step
Check Product Details
Verify the model number 9323-5310 on the femoral offset bushing (0mm or 4mm) to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “US Nationwide distribution in the states of Texas and Michigan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Michigan, Texas.
Recall timeline
FDA published this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2897-2026 (March 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2897-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.